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Japan Medical Device Nomenclature (JMDN)

  • Global medical device nomenclature compared to Japan medical device nomenclature (GMDN vs. JMDN) based off GHTF SG1-N15

  • JMDN and GMDN are similar, but not the same

  • Must know the JMDN Code for a product family in order to understand the route to compliance.... similar to FDA Product Codes

  • JMDN defines the definition of subject device and each medical device must be within the scope of applied definition to register.

  • English database for look-up is available at PMDA's website

  • Translated Example:

      JMDN: Passer, suture, single-use (Code:37839002)

      Classification: Class II

      Definition: A surgical instrument for passing sutures and suture needles through tissue

      Certification Standard: No. 425: Certification Standard for Single use products to which T0993-1 is applied

      Applicable JIS: JIS T0993-1

      Intended Use: To be used for puncturing a hole through tissue to pass sutures or suture needles.